Helsinn Birex Pharmaceuticals is currently seeking an experienced Production Manager to lead and optimise our production operations within a GMP-regulated environment.
Reporting to the Manufacturing, Science and Technology Director, this role will be responsible for the day-to-day management of production activities, driving operational excellence, and ensuring delivery of production targets in line with quality, safety and regulatory requirements.
The successful candidate will play a key role in continuous improvement initiatives, cross-functional collaboration, and strategic operational planning, contributing directly to site performance and business objectives.
Key Responsibilities
Lead and manage daily manufacturing and packaging operations to ensure production targets, quality standards and timelines are achieved.
As the Production SME on the OPEX fusion team, drive Operational Excellence / Lean / Six Sigma initiatives identified to improve yield, reduce waste, increase efficiency and optimise process flow.
Monitor production performance through KPIs, reporting the results in the Metrics fusion team, analyse trends and implement corrective and preventive actions.
In collaboration with the Supply Chain Operations function, manage production scheduling, capacity planning and resource allocation.
Collaborate closely with Quality, Engineering, Maintenance and Supply Chain to ensure compliance with cGMP and operational requirements.
Oversee deviation management, root cause analysis and implementation of CAPAs.
Support new product introductions and ensure seamless integration into manufacturing processes.
Lead, develop and coach a high-performing team, including supervisors and administrators, ensuring appropriate training and performance management.
Participate in audits (internal and external) and ensure inspection readiness at all times.
Contribute to budget planning, cost control and capital project management.
Prepare and present production reports and operational updates to senior management.
Required Qualifications and Experience
Third-level qualification in a technical or scientific discipline.
Minimum of 5 years’ experience in a pharmaceutical manufacturing environment, preferably within OSD operations, operating under GMP regulations (EU/HPRA/FDA and global standards).
Proven experience in people management and leadership within a production environment.
Strong knowledge of manufacturing processes, serialisation, deviation systems and quality compliance.
Experience with ERP/MES systems.
Experience in aseptic / sterile manufacturing is highly desirable.
Demonstrated experience in continuous improvement / Operational Excellence initiatives.
Strong leadership and team development capabilities.
Results-driven with a focus on performance, quality and continuous improvement.
Excellent problem-solving and analytical skills.
Effective communication and stakeholder management across functions.
High level of organisation and ability to manage multiple priorities.
Strong understanding of GMP, EHS and regulatory requirements.
Proactive mindset with the ability to drive change and innovation.
#J-18808-Ljbffr